SPECTRAL'S 2 IN 1 (TNI-MYO)— 510(k) K020950

Substantially Equivalent

Spectral Diagnostics, Inc.

FDA 510(k) clearance K020950 for SPECTRAL'S 2 IN 1 (TNI-MYO), Substantially Equivalent on 2002-05-24. Applicant: Spectral Diagnostics, Inc..

Clearance details

Applicant: Spectral Diagnostics, Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2002-03-25
Decision date: 2002-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

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Adverse events under product code MMI

product code MMI

Injury: 172
Malfunction: 3,762
Total: 3,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.